Carbon Ion Radiotherapy for Atypical Meningiomas (MARCIE)
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|ClinicalTrials.gov Identifier: NCT01166321|
Recruitment Status : Unknown
Verified July 2010 by University Hospital Heidelberg.
Recruitment status was: Not yet recruiting
First Posted : July 21, 2010
Last Update Posted : August 2, 2010
Treatment standard for patients with atypical or anaplastic meningioma is neurosurgical resection. With this approach, local control ranges between 50 and 70%, depending on resection status. A series or smaller studies has shown that postoperative radiotherapy in this patient population can increase progression-free survival, which translates into increased overall survival. However, meningiomas are known to be radioresistant tumors, and radiation doses of 60 Gy or higher have been shown to be necessary for tumor control.
Carbon ions offer physical and biological characteristics. Due to their inverted dose profile and the high local dose deposition within the Bragg peak precise dose application and sparing of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an increased relative biological effectiveness (RBE), which can be calculated between 2 and 5 depending on the cell line as well as the endpoint analyzed.
First data obtained within the Phase I/II trial performed at GSI in Darmstadt on carbon ion radiotherapy for patients with high-risk meningiomas has shown safety, and treatment results are promising.
Therefore, in the current Phase II-MARCIE-Study a carbon ion boost will be applied to the macroscopic tumor (gross tumor volume, GTV) in conjunction with photon radiotherapy to the clinical target volume (CTV) in patients with atypical meningiomas after incomplete resection or biopsy.
Primary endpoint is progression-free survival rate, secondary endpoints are overall survival, safety and toxicity.
|Condition or disease||Intervention/treatment||Phase|
|Meningioma||Radiation: Carbon Ion Radiotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Patients With Atypical Meningiomas Simpson Grade 4 and 5 With a Carbon Ion Boost in Combination With Postoperative Photon Radiotherapy: A Phase II Trial|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||July 2013|
Experimental: Carbon Ion Radiotherapy Boost
Carbon Ion Boost to the Macroscopic Tumor visible on contrast-enhanced MR-Imaging
Radiation: Carbon Ion Radiotherapy
Carbon Ion Boost 18 Gy E in single Fractions of 3 Gy E
- Progression-free survival [ Time Frame: Progression-free survival at 3 years ]
- Overall Survival [ Time Frame: Overall Survival at 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01166321
|Contact: Jürgen Debus, MD PhD||+49-6221-56- ext firstname.lastname@example.org|
|Contact: Stephanie E Combs, MD||+49-6221-56- ext email@example.com|
|University Hospital of Heidelberg, Radiation Oncology|
|Heidelberg, Germany, 69120|